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Terminated

Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-10. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

FDA Recall Z-0377-2010 · Posted 2009-11-24

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2009-07-01
Date Terminated2011-10-05
Product Quantity327 of total product

Reason for Recall

The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.

Firm Action

On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.

Root Cause

Other

Distribution Pattern

Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090596ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMZimmer, Inc. · 2009-06-30K083497ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILSZimmer, Inc. · 2009-02-19K082770ZIMMER NATURAL NAIL SYSTEM TIBIAL NAILZimmer, Inc. · 2008-12-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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